EDSA

TORONTO, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three and nine months ended June 30, 2026 and provided an update on its business. During the third quarter, Edesa completed preparations for its Phase 2 clinical study of EB06 (an anti-CXCL10 monoclonal antibody) in patients with moderate-to-severe nonsegmental vitiligo. Subsequent to quarter-end, the company began activating its first investigational sites and expects recruitment to begin in the coming weeks in Canada, with additional jurisdictions to follow, subject to regulatory approval and administrative filings. In its respiratory program, the company conducted additional exploratory analyses to evaluate paridiprubart’s effect in ARDS patients with concurrent acute kidney injury (AKI). In this population, paridiprubart plus standard of care treatment was associated with significant mortality reductions supported by concordant improvements in the kidney-specific MAKE30 composite endpoint. Edesa continues to evaluate potential regulatory pathways in major markets while advancing strategic discussions for the program. "Our third quarter marked an important operational inflection point for Edesa, with the completion of preparations for our Phase 2 vitiligo study keeping us on track for initial enrollment in the coming weeks," said Par Nijhawan, MD, Chief Executive Officer of Edesa. "In addition, the positive exploratory data in patients with acute kidney injury further reinforce the versatility of paridiprubart and support our engagement with potential partners as we advance late-stage development and evaluate future commercialization pathways." Edesa’s Chief Financial Officer Peter Weiler said third quarter results tracked to the company’s operating plan, with spending beginning to shift from preparatory activities toward clinical trial execution. “We are prioritizing execution of the EB06 Phase 2 study while continuing to support regulatory, manufacturing and business development activities for paridiprubart,” he said. Financial Results for the Three Months Ended June 30, 2026 Total operating expenses increased by $3.6 million to $5.5 million for the three months ended June 30, 2026 compared to $1.9 million for the same period last year: Research and development expenses increased by $3.1 million to $4.0 million for the three months ended June 30, 2026 compared to $0.9 million for the same period last year primarily due to increased expenses for manufacturing-related activities and other preparations for the planned Phase 2 clinical study of EB06 in vitiligo patients, as well as increased unallocated research costs, which were partially offset by decreased expenditures for the company’s paridiprubart program. General and administrative expenses increased by $0.6 million to $1.6 million for the three months ended June 30, 2026 compared to $1.0 million for the same period last year primarily due to increases in noncash share-based compensation and professional fees. Total other income decreased by approximately $42,000 to $112,000 for the three months ended June 30, 2026 compared to $154,000 for the same period last year, primarily due to a decrease in reimbursement funding from the Canadian government's Strategic Response Fund, which was partially offset by a favorable impact from foreign currency exchange. For the quarter ended June 30, 2026, Edesa reported a net loss of $5.4 million, or $0.60 per common share, compared to a net loss of $1.7 million, or $0.25 per common share, for the quarter ended June 30, 2025. Financial Results for the Nine Months Ended June 30, 2026 Total operating expenses increased by $6.8 million to $12.2 million for the nine months ended June 30, 2026 compared to $5.4 million for the same period last year: Research and development expenses increased by $5.4 million to $7.8 million for the nine months ended June 30, 2026 compared to $2.4 million for the same period last year primarily due to increased expenses for manufacturing-related activities and other preparations for the planned Phase 2 clinical study of EB06 in vitiligo patients, as well as increased unallocated research costs, which were partially offset by decreased expenditures for the company’s paridiprubart program. General and administrative expenses increased by $1.3 million to $4.3 million for the nine months ended June 30, 2026 compared to $3.0 million for the same period last year primarily due to increases in noncash share-based compensation and professional fees. Total other income decreased by $200,000 to $285,000 for the nine months ended June 30, 2026 compared to $485,000 for the same period last year, primarily due to a decrease in reimbursement funding from the Canadian government's Strategic Response Fund, which was partially offset by a favorable impact from foreign currency exchange. For the nine months ended June 30, 2026, Edesa reported a net loss of $11.9 million, or $1.40 per common share, compared to a net loss of $5.0 million, or $0.95 per common share, for the nine months ended June 30, 2025. Working Capital At June 30, 2026, Edesa had cash and cash equivalents of $10.3 million and working capital of $6.9 million. Calendar Edesa management is scheduled to participate in the H.C. Wainwright 28th Annual Global Investment Conference to be held September 12-13, 2026 in New York, NY. Attendees interested in meeting with company representatives can request meetings through the conference organizers or by contacting Edesa directly at [email protected]. About Edesa Biotech, Inc. Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is paridiprubart, which is being developed as a potential treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. The paridiprubart program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset, and is currently being evaluated in a U.S. government-funded platform study. Edesa is also pursuing additional uses for paridiprubart. Sign up for news alerts. Connect with us on X and LinkedIn. Edesa Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company's plans and expectations regarding the conduct of its Phase 2 clinical study of EB06 in vitiligo patients; the company's expectation that patient recruitment and enrollment will commence in the coming weeks in Canada, with additional jurisdictions to follow, subject to regulatory approvals and any required administrative filings; the company's belief that findings from its exploratory analyses in ARDS patients with acute kidney injury at baseline further support the therapeutic potential of paridiprubart; the company's plans to evaluate potential regulatory pathways for paridiprubart in major markets; the company's plans to engage in strategic and business development discussions regarding paridiprubart, including with potential partners, and the potential outcomes of such discussions; the company's plans to advance paridiprubart through late-stage development and evaluate future commercialization opportunities; the company's belief that the third quarter represented an important operational milestone for the company; the company's expectations regarding the shift in spending from preparatory activities toward clinical trial execution and the composition of its operating expenses; the company's plans regarding capital allocation, including prioritizing execution of the Phase 2 EB06 study while continuing to support regulatory and business development activities for paridiprubart; and the company's timing and plans regarding its clinical programs in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements. Contact:Gary KoppenjanEdesa Biotech, [email protected]

TORONTO, May 14, 2026 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three and six months ended March 31, 2026 and provided an update on its business. During the second quarter, Edesa continued preparations for an upcoming Phase 2 clinical study of its drug candidate, EB06 (an anti-CXCL10 monoclonal antibody), in moderate-to-severe nonsegmental vitiligo patients. The company reported that it has contracted a clinical research organization and initiated outreach to potential clinical sites and investigators. Based on this progress, Edesa reaffirmed its previous guidance that site activations and patient recruitment are expected to begin midyear 2026, subject to regulatory approval. For its respiratory program, the company also announced during the quarter additional positive data from its Phase 3 study of paridiprubart in subjects with Acute Respiratory Distress Syndrome. Most notably, treatment benefits were consistent across disease severity groups and in those patients with serious comorbidities, including acute kidney injury, pneumonia and sepsis. “Our second quarter progress reflects the meaningful strides we are making across both our medical dermatology and respiratory programs,” said Par Nijhawan, MD, Chief Executive Officer of Edesa. “In dermatology, our vitiligo program is on track and we are executing against our clinical milestones. Alongside this, the new Phase 3 data for paridiprubart are particularly encouraging, and the consistent treatment benefits demonstrated across patient subgroups reinforce our confidence in this asset's potential to address critical care medicine's most challenging conditions.” Edesa's Chief Financial Officer Peter Weiler reported that financial results for the second quarter reflected a continuation of trends from the prior period and were in line with management expectations. "We are pleased with the progress being made in our EB06 program as we advance the foundational work needed to bring this study to patients. As anticipated, operating expenses have edged higher in line with these preparations, and we expect that trend to continue as program activity builds,” he said. Financial Results for the Three Months Ended March 31, 2026 Total operating expenses increased by $2.7 million to $4.3 million for the three months ended March 31, 2026 compared to $1.6 million for the same period in the last year: Research and development expenses increased by $2.3 million to $2.8 million for the three months ended March 31, 2026 compared to $0.5 million for the same period last year primarily due to increased expenses for manufacturing-related activities and other preparations for the planned Phase 2 clinical study of EB06 in vitiligo patients; increased expenses related to regulatory and manufacturing readiness for paridiprubart; and increased unallocated research costs. General and administrative expenses increased by $0.3 million to $1.5 million for the three months ended March 31, 2026 compared to $1.2 million for the same period year primarily due to an increase in salaries and related costs, and professional fees. Total other income increased by $30,000 to $79,000 for the three months ended March 31, 2026 compared to $49,000 for the same period last year, primarily due to an increase in reimbursement funding from the Canadian government's Strategic Response Fund and a favorable impact from foreign currency exchange. For the quarter ended March 31, 2026, Edesa reported a net loss of $4.2 million, or $0.49 per common share, compared to a net loss of $1.6 million, or $0.30 per common share, for the quarter ended March 31, 2025. Financial Results for the Six Months Ended March 31, 2026 Total operating expenses increased by $3.1 million to $6.6 million for the six months ended March 31, 2026 compared to $3.5 million for the same period last year: Research and development expenses increased by $2.4 million to $3.9 million for the six months ended March 31, 2026 compared to $1.5 million for the same period last year primarily due to increased expenses for manufacturing-related activities and other preparations for the planned Phase 2 clinical study of EB06 in vitiligo patients, as well as increased unallocated research costs, which were partially offset by decreased expenses related to the completion of the Phase 3 study of paridiprubart. General and administrative expenses increased by $0.7 million to $2.7 million for the six months ended March 31, 2026 compared to $2.0 million for the same period year primarily due to an increase in salaries and related costs, and professional fees. Total other income decreased by $158,000 to $173,000 for the six months ended March 31, 2026 compared to $331,000 for the same period last year, primarily due to a decrease in reimbursement funding from the Canadian government's Strategic Response Fund, which was partially offset by a favorable impact from foreign currency exchange. For the six months ended March 31, 2026, Edesa reported a net loss of $6.5 million, or $0.78 per common share, compared to a net loss of $3.2 million, or $0.74 per common share, for the six months ended March 31, 2025. Working Capital At March 31, 2026, Edesa had cash and cash equivalents of $10.0 million and working capital of $8.2 million. Calendar Edesa plans to participate in the Respiratory Innovation Summit from May 15-16, 2026; the American Thoracic Society (ATS) 2026 International Conference from May 15-20. 2026; the Dermatology Drug Development Summit from May 19-21, 2026; and the BIO International Convention being held June 22-25, 2026. Attendees interested in meeting with company representatives can request meetings through the conference organizers or by contacting Edesa directly at [email protected]. About Edesa Biotech, Inc. Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is paridiprubart, which is being developed as a potential treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The paridiprubart program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset, and is currently being evaluated in a U.S. government-funded platform study. Edesa is also pursuing additional uses for paridiprubart. Sign up for news alerts. Connect with us on X and LinkedIn. Edesa Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company’s plans for an upcoming Phase 2 study in moderate-to-severe nonsegmental vitiligo; the company’s belief that site activations and patient recruitment for its vitiligo study will begin midyear 2026; the company’s belief that second quarter progress reflects the meaningful strides across both its medical dermatology and respiratory programs; the company’s belief that its vitiligo program is on track and staff are executing against the company’s clinical milestones; the company’s belief that paridiprubart has the potential to address critical care medicine's most challenging conditions; the company’s belief that trends for increased operating expenses will continue as program activity builds; and the company's timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements. Contact: Gary Koppenjan Edesa Biotech, Inc. [email protected]

Results in a population of 278 patients affirm statistically significant mortality reductions Benefits observed across severity groups and in subjects with serious comorbidities Company files provisional patent applications for sepsis, acute kidney injury and pneumonia Strategic collaborations to support late-stage development and commercialization being evaluated Study results selected for oral presentation at ATS 2026 conference TORONTO, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, announced today positive additional data from a Phase 3 study of paridiprubart. The results represent a broader, 278-patient population, which includes both previously reported 104 patients requiring invasive mechanical ventilation (IMV) as well as 174 non-IMV patients. Across this full population, the company’s first-in-class anti-TLR4 antibody demonstrated a statistically significant reduction in 28-day mortality. Treatment benefits were consistent across severity groups and in patients with serious comorbidities. Key Findings The primary endpoint was achieved for the full treatment population of 278 randomized subjects. Paridiprubart reduced adjusted 28-day mortality to 24% from 33%, a 27% relative reduction in the risk of death (p<0.001). In addition, subjects receiving paridiprubart demonstrated a higher relative rate of clinical improvement by Day 28. Paridiprubart or placebo were provided in addition to standard of care treatments (SOC). In an exploratory analysis of a milder population of 174 randomized patients who did not meet the study’s IMV-based inclusion criteria, paridiprubart + SOC reduced adjusted 28-day mortality to 15% from 23% (placebo + SOC), a 35% relative reduction in the risk of death (p<0.05). Edesa also reported that exploratory analyses across a patient population of up to 108 randomized subjects consistently demonstrated reduced adjusted mortality for paridiprubart + SOC vs. placebo + SOC at 28 days in subjects with clinically important comorbidities: Acute Kidney Injury: 35% relative reduction (35% paridiprubart vs. 53% placebo; p<0.05, n=48) Sepsis: 36% relative reduction (40% paridiprubart vs. 63% placebo; p<0.05, n=41) Pneumonia: 30% relative reduction (35% paridiprubart vs. 49% placebo; p<0.05, n=108) Overall rates of adverse events, serious adverse events, infections and treatment discontinuations were low and similar between the paridiprubart and placebo groups. The safety profile was consistent with prior clinical exposures, with more than 400 patients now having received paridiprubart. Based in part on these positive results, Edesa has filed provisional patent applications with the United States Patent and Trademark Office covering the use of paridiprubart in the treatment of sepsis, acute kidney injury and pneumonia. The company’s core composition-of-matter patents extend into the 2030s. Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech, said that the results announced today align with the central role of TLR4 in hyperinflammatory ARDS (Acute Respiratory Distress Syndrome) and demonstrate consistent benefit across high-mortality etiologies. “The consistency of mortality reduction and clinical improvement across all 278 randomized patients, including less severe patients as well as those with ARDS complicated by acute kidney injury, sepsis and pneumonia, underscores the versatility and transformative potential of paridiprubart to address multiple critical unmet medical needs,” said Dr. Nijhawan. “We are advancing regulatory discussions and evaluating strategic collaborations and partnership opportunities that could accelerate development and broaden global access.” He noted that manufacturing scale-up planning is underway. Paridiprubart is currently being evaluated in a separate U.S. government-funded study of ARDS patients. Enrollment is ongoing for up to approximately 200 randomized subjects for the Edesa cohort. The company’s paridiprubart development program, including manufacturing scale-up, late-stage development and commercial readiness, also receives funding from the Government of Canada. Edesa has been selected for an oral presentation at the American Thoracic Society (ATS) 2026 International Conference (May 15-20, 2026) and plans to present additional findings from its Phase 3 study at other upcoming medical and scientific conferences. Detailed Results Data were derived from the full study safety population of 278 patients; the previously reported 104-patient IMV ITT cohort represents a prespecified subset of this population. Patients in the full 278-patient safety population were randomly assigned (1:1) to SOC with paridiprubart (n=138), or SOC with placebo (n=140). Baseline characteristics and SOC were balanced between treatment groups. The following tables summarize the key additional results: Primary Endpoint: Mortality Rate at 28 Days Multivariate Logistic Regression Derived Risk Differences, 95%CI Adjusted model derived adjusted mortality estimates: variables included age, baseline WHO Covid-19 Severity Scale (WCSS), baseline antiviral use, baseline corticosteroid use, baseline immunomodulator use, concomitant antiviral use, concomitant corticosteroid use, concomitant immunomodulator use. All (safety population) n=278; Intent to treat (ITT) IMV population n=104 Secondary Endpoint: Achievement of ≥2-Point Improvement in WCSS at 28 Days Multivariate Logistic Regression Derived Risk Differences, 95%CI Adjusted risk estimate: variables included age, baseline WCSS, baseline antiviral use, baseline corticosteroid use, baseline immunomodulator use, concomitant antiviral use, concomitant corticosteroid use, concomitant immunomodulator use. Safety population n=278; ITT IMV population n=104 Exploratory Analysis: Mortality Rate at 28 Days Multivariate Logistic Regression Derived Risk Differences, 95%CI *Nominal p-value, not adjusted for multiplicity Methodology and Background Consistent with the original analysis, all prespecified efficacy evaluations were conducted under the same statistical analysis plan (SAP) using an identical multivariate logistic regression model and the same covariates. The SAP defined a hierarchical testing structure for adjusted 28‑day mortality for the full 278‑patient population as well as the 104‑patient IMV ITT population. Both analyses were prespecified and locked prior to unblinding. Exploratory analyses were subsequently conducted for the 174 non‑IMV randomized subjects, using the same model and covariates. Additional exploratory analyses were conducted for subjects with acute kidney injury, sepsis or pneumonia, using the same model but with subgroup‑appropriate covariates to account for clinical differences. The study was managed and analyses were conducted by JSS Medical Research, an international contract research organization. About Paridiprubart Paridiprubart represents a new class of host directed therapeutics (HDTs) that are designed to modulate the body's own immune response when confronted with known or unknown public health threats such as novel infectious diseases as well as chemical, biological, radiological, and nuclear incidents. Importantly, HDTs are agnostic to the causal agent and can be stockpiled preemptively to respond to public health emergencies and biodefense. Mechanistically, paridiprubart inhibits toll-like receptor 4 (TLR4), a key immune signaling protein that has been shown to be activated by viruses, bacteria, injury/trauma and in the pathogenesis of chronic autoimmune diseases. About ARDS Acute Respiratory Distress Syndrome involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few recommended treatments other than supplemental oxygen and mechanical ventilation, and mortality rates are high. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury, and other causes. ARDS accounts for 10% of intensive care unit admissions, representing more than 3 million patients globally each year. About Edesa Biotech Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is EB05 (paridiprubart), which is being evaluated in a U.S. government-funded platform study as a treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The EB05 program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset. Edesa is also pursuing additional uses for paridiprubart. Sign up for news alerts. Connect with us on X and LinkedIn. Edesa Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company's belief that its existing resources are sufficient to achieve its near-term clinical milestones; the company’s belief that results announced today align with the central role of TLR4 in hyperinflammatory ARDS and demonstrate consistent benefit across high mortality etiologies; the company’s belief that the consistency of mortality reduction across 278 randomized patients, including those with ARDS complicated by acute kidney injury, sepsis and pneumonia, underscores the versatility and transformative potential of paridiprubart to address multiple critical unmet medical needs; the company’s plans to advance regulatory discussions and evaluate strategic collaborations and partnership opportunities that could accelerate development and broaden global access; the company’s planning for manufacturing scale up; the company’s expectation that the U.S. government funded study will randomize up to 200 subjects in the paridiprubart cohort; the company’s expectation that the Canadian government will continue to support development; the company’s plans to present more detailed findings at upcoming medical and scientific conferences; and the company's timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements. Contact: Gary Koppenjan Edesa Biotech, Inc. [email protected]

TORONTO, Feb. 13, 2026 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three months ended December 31, 2025 and provided an update on its business. During the first quarter, Edesa progressed manufacturing of its dermatology drug candidate, EB06 (an anti-CXCL10 monoclonal antibody), and placebo for an upcoming Phase 2 study in moderate-to-severe nonsegmental vitiligo. The company anticipates recruitment will begin midyear 2026, subject to regulatory approvals. In its respiratory program, Edesa reported that it is evaluating subgroup data for additional efficacy signals among subjects with certain comorbidities following positive results from a Phase 3 study of its monoclonal antibody, paridiprubart, in patients with Acute Respiratory Distress Syndrome. The company plans to present its Phase 3 respiratory and subgroup data at upcoming scientific and medical conferences. “Manufacturing plans for our upcoming vitiligo study are on schedule, and we are advancing the EB06 program toward regulatory readiness and launch,” said Par Nijhawan, MD, Chief Executive Officer of Edesa. “In parallel, we are utilizing positive Phase 3 data to explore accelerated commercialization pathways as well as potential broader strategic opportunities for paridiprubart.” Edesa's Chief Financial Officer Peter Weiler reported that financial results for the first quarter reflected the continuation of trends from the preceding period, including the ramp up in activities for the company’s vitiligo drug development program as well as the completion of the Phase 3 clinical study of paridiprubart. “Management remains disciplined in deploying resources and executing in line with our plans. Going forward, we anticipate that research expenditures will generally track activity in our EB06 program, including the manufacturing of clinical drug supplies. We continue to evaluate opportunities to achieve our clinical objectives more efficiently, such as establishing investigational sites across multiple jurisdictions to provide greater cost and operational flexibility.” Financial Results for the Three Months Ended December 31, 2025 Total operating expenses increased by $0.4 million to $2.3 million for the three months ended December 31, 2025 compared to $1.9 million for the same period in the previous year: Research and development expenses increased by $0.1 million to $1.1 million for the three months ended December 31, 2025 compared to $1.0 million for the same period last year primarily due to increased expenses for manufacturing-related activities and other preparations for a planned Phase 2 clinical study of EB06 in vitiligo patients, as well as increased unallocated research costs, which were offset by decreased expenses related to the completion of the Phase 3 study of paridiprubart. General and administrative expenses increased by 0.3 million to $1.2 million for the three months ended December 31, 2025 compared to $0.9 million for the same period year primarily due to an increase in noncash share-based compensation. Total other income decreased by $0.2 million to $0.1 million for the three months ended December 31, 2025 compared to $0.3 million for the same period last year, primarily due to a decrease in reimbursement funding from the Canadian government's Strategic Response Fund. For the quarter ended December 31, 2025, Edesa reported a net loss of $2.2 million, or $0.28 per common share, compared to a net loss of $1.6 million, or $0.48 per common share, for the quarter ended December 31, 2024. Working Capital At December 31, 2025, Edesa had cash and cash equivalents of $12.1 million and working capital of $12.0 million. Calendar Edesa plans to participate in the Global Vitiligo Foundation Annual Scientific Symposium on March 26, 2026; BIO Europe Spring 2026 from March 23-25, 2026; the Respiratory Innovation Summit from May 15-16, 2026; the American Thoracic Society (ATS) 2026 International Conference from May 15-20. 2026; and the Dermatology Drug Development Summit from May 19-21, 2026. Attendees interested in meeting with company representatives can request meetings through the conference organizers or by contacting Edesa directly at [email protected]. About Edesa Biotech, Inc. Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is paridiprubart, which is being developed as a potential treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The paridiprubart program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset, and is currently being evaluated in a U.S. government-funded platform study. Edesa is also pursuing additional uses for paridiprubart. Sign up for news alerts. Connect with us on X and LinkedIn. Edesa Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: The company’s plans for an upcoming Phase 2 study in moderate-to-severe nonsegmental vitiligo; the company’s belief that recruitment for its vitiligo study will begin midyear 2026, subject to regulatory approvals; the company’s plans to present its Phase 3 respiratory and subgroup data at upcoming scientific and medical conferences; the company’s belief that its manufacturing plans for the vitiligo study are on schedule and advancing toward regulatory readiness and launch; the company’s belief that positive Phase 3 data for paridiprubart creates opportunities for accelerated commercialization pathways as well as potential broader strategic opportunities for the drug candidate; management’s intentions to remain disciplined in deploying resources and executing in line with its plans; the company’s anticipation that research expenditures will generally track activity in its EB06 program, including the manufacturing of clinical drug supplies; the company’s intention to evaluate opportunities to achieve its clinical objectives more efficiently, such as establishing investigational sites across multiple jurisdictions to provide greater cost and operational flexibility; and the company's timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements. Contact: Gary Koppenjan Edesa Biotech, Inc. [email protected]

TORONTO, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the fiscal year ended September 30, 2025 and provided an update on its business. During the year, the company initiated manufacturing activities for a Phase 2 study of Edesa’s dermatology drug candidate, EB06 (an anti-CXCL10 monoclonal antibody), in patients with moderate-to-severe nonsegmental vitiligo. Edesa anticipates that recruitment will begin by midyear 2026, subject to the completion of clinical-grade drug manufacturing and regulatory approvals. In its respiratory program, Edesa reported that a Phase 3 study of its monoclonal antibody, paridiprubart (EB05), met primary and secondary endpoints with statistical significance. Edesa is currently exploring development and commercialization partnerships for paridiprubart as well as expedited regulatory pathways that may be available in certain jurisdictions. “Our strategy to advance a high-impact dermatology asset alongside a now-validated respiratory therapeutic is bearing fruit, and we believe Edesa is well positioned for our mission to deliver transformative therapies to patients with high unmet medical needs,” said Par Nijhawan, MD, Chief Executive Officer of Edesa. “With new momentum and data in hand, we are engaging with potential strategic and government partners to seek additional non-dilutive support and collaborative arrangements that advance our programs.” Edesa's Chief Financial Officer Peter Weiler reported that financial results for the fiscal year reflected a ramp up in activities for the company’s vitiligo program as well as the completion and close-out of the Phase 3 clinical study of paridiprubart. “This year, we strengthened our balance sheet and extended our Canadian government funding agreement to support manufacturing and development for our respiratory program. Looking ahead, our priorities include executing the Phase 2 vitiligo study, advancing respiratory assets toward partnering and commercialization, expanding manufacturing capacity, and maintaining financial discipline,” he said. Financial Results for the Fiscal Year Ended September 30, 2025 Total operating expenses increased by $0.9 million to $7.9 million for the year ended September 30, 2025 compared to $7.0 million for the prior year: Research and development expenses increased by $0.8 million to $3.7 million for the year ended September 30, 2025 compared to $2.9 million for the prior year primarily due to increased expenses for manufacturing-related activities and other preparations for a planned Phase 2 clinical study of EB06 in vitiligo patients, as well as increased external research expenses related to the completion of a Phase 3 study of paridiprubart (EB05) and drug supply costs for an ongoing U.S. government study of paridiprubart, partially offset by lower spend on other development programs. General and administrative expenses increased by $0.1 million to $4.2 million for the year ended September 30, 2025 compared to $4.1 million for the prior year primarily due to an increase in noncash share-based compensation, which was partially offset by a decrease in professional fees. Total other income decreased by $0.1 million to $0.7 million for the year ended September 30, 2025 compared to $0.8 million for the prior year, primarily due to a decrease in interest income, which was partially offset by an increase in reimbursement funding from the Canadian government's Strategic Innovation Fund. For the year ended September 30, 2025, Edesa reported a net loss of $7.2 million, or $1.27 per common share, compared to a net loss of $6.2 million, or $1.93 per common share, for the year ended September 30, 2024. Working Capital At September 30, 2025, Edesa had cash and cash equivalents of $10.8 million and working capital of $10.4 million. Subsequent to the fiscal year end, the company received $3.4 million in net proceeds, after deducting sales agent commissions, from common shares sold under an at-the-market offering program. Calendar Edesa management plans to participate in one-on-one meetings during JP Morgan week, which begins on January 12, 2026, in San Francisco, California. Attendees interested in meeting with management can request meetings by contacting Edesa at [email protected]. About Edesa Biotech, Inc. Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is paridiprubart, which is being developed as a potential treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The paridiprubart program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset, and is currently being evaluated in a U.S. government-funded platform study. Edesa is also pursuing additional uses for paridiprubart in chronic respiratory diseases. Sign up for news alerts. Connect with us on X and LinkedIn. Edesa Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: anticipated initiation of patient recruitment for a Phase 2 vitiligo study by midyear 2026, subject to manufacturing and regulatory approvals; efforts to pursue development and commercialization partnerships for paridiprubart; potential expedited regulatory pathways; strategic initiatives to secure non-dilutive funding and collaborative arrangements; ongoing priorities such as executing clinical studies, advancing respiratory assets toward partnering and commercialization, expanding manufacturing capacity, and maintaining financial discipline; and the company's timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements. Contact: Gary Koppenjan Edesa Biotech, Inc. [email protected]

Study met primary and secondary endpoints Paridiprubart demonstrated a relative reduction in the risk of death of 25% Treatment provided patients with clinically meaningful improvement in survival and recovery Paridiprubart exhibited consistent safety and tolerability profile TORONTO, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics (HDTs) for immuno-inflammatory diseases, today announced positive results from a Phase 3 study evaluating the company’s drug candidate paridiprubart (EB05) as a treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. The data from the Phase 3 study demonstrated that paridiprubart met primary and secondary endpoints with statistical significance. Paridiprubart led to a clinically significant reduction in mortality through 60 days, as well as a significant reduction in the proportion of patients requiring invasive mechanical ventilation (IMV). Edesa reported that paridiprubart in the most conservative intention-to-treat (ITT) population met the primary endpoint, demonstrating a statistically significant and clinically meaningful benefit for reduced mortality at 28 days. Patients treated with paridiprubart plus standard of care treatments (SOC) had a lower risk of death (39%) compared to those receiving placebo (52%), representing an absolute improvement in survival of 13% at 28 days with paridiprubart demonstrating a relative reduction in the risk of death of 25% compared to placebo (n=104; p<0.001). A durable survival benefit was also demonstrated at 60 days, with patients treated with paridiprubart plus SOC demonstrating a lower risk of death (46%) compared to those receiving placebo (59%), representing an absolute improvement in survival of 13% with a relative risk reduction of 22% for paridiprubart compared to placebo (n=104; p=0.003). In addition, subjects receiving paridiprubart + SOC demonstrated a 41% higher relative rate of clinical improvement, meaning patients no longer required IMV and/or organ support at Day 28. The results from a safety population of more than 275 subjects, which included patients enrolled during the interim between the Phase 2 and Phase 3 study, demonstrated that EB05 was generally well-tolerated and consistent with the observed safety profile to date. Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech, said the Phase 3 data further demonstrate the transformative potential of EB05 to improve survival and ICU hospitalization outcomes. “We are encouraged by these positive Phase 3 results, which demonstrated meaningful improvements in outcomes for patients. These data indicate that paridiprubart provided a consistent and durable effect in patients across all severity groups evaluated. We believe that these findings not only provide important validation of our therapeutic approach but also support paridiprubart’s potential use as a standard of care treatment for ARDS, and potentially chronic respiratory indications as well.” Paridiprubart is currently being evaluated in the U.S. government’s “Just Breathe” study investigating three novel threat-agnostic therapeutics in hospitalized adult patients with ARDS. Edesa’s paridiprubart development program, including this Phase 3 study and manufacturing scale-up, also receives funding from the Government of Canada’s Strategic Innovation Fund. The study was managed and all analyses were conducted by JSS Medical Research, an international contract research organization. Detailed Results Patients were enrolled from 38 hospitals in the USA, Canada and Colombia. Participants were 18 years or older, receiving IMV with or without additional organ support at the time of hospitalization. They were randomly assigned (1:1) to SOC with paridiprubart (15mg/kg, maximum dose of 1400mg, n=56), or SOC with placebo (n=48). Efficacy outcomes were 28-day and 60-day mortality and proportion of patients with a decrease of ≥ 2 points in the WHO COVID-19 Severity Scale (WCSS) at 28-days. The company opted to discontinue enrollment early for business reasons. Patient demographics and baseline disease parameters were similar for the two groups with overall mean (SD) age: 52 (20-86) years, female (34%), severe ARDS (55%); moderate ARDS (38%); mild ARDS (5%), antivirals (10%), corticosteroids (44%), immunomodulators (10%), IMV only (36%), IMV with additional organ support (64%), acute kidney injury (26%), sepsis (20%), pneumonia (40%). The following tables summarize the key results from the truncated Phase 3 study. Mortality Rate at 28 Days and 60 Days Multivariate Logistic Regression Derived Risk Differences, 95%CI* Achievement of ≥2-Point Improvement in WCSS at 28 Days Multivariate Logistic Regression Derived Risk Differences, 95%CI* About Paridiprubart Paridiprubart represents a new class of host directed therapeutics (HDTs) that are designed to modulate the body's own immune response when confronted with known or unknown public health threats such as novel infectious diseases as well as chemical, biological, radiological, and nuclear incidents. Importantly, HDTs are agnostic to the causal agent and can be stockpiled preemptively to respond to public health emergencies and biodefense. Mechanistically, paridiprubart inhibits toll-like receptor 4 (TLR4), a key immune signaling protein that has been shown to be activated by viruses, bacteria, injury/trauma and in the pathogenesis of chronic autoimmune diseases. About ARDS Acute Respiratory Distress Syndrome involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few recommended treatments other than supplemental oxygen and mechanical ventilation, and mortality rates are high. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury, and other causes. ARDS accounts for 10% of intensive care unit admissions, representing more than 3 million patients globally each year. About Edesa Biotech, Inc. Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is EB05 (paridiprubart), which is being evaluated in a U.S. government-funded platform study as a treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The EB05 program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset. Edesa is also pursuing additional uses for paridiprubart in chronic diseases, such as pulmonary fibrosis. Sign up for news alerts. Connect with us on X and LinkedIn. Edesa Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company’s belief that the Phase 3 data of EB05 presented herein demonstrate the transformative potential of EB05 to improve medical outcomes; the company’s belief that these results demonstrated meaningful improvements in outcomes for patients; the company’s belief that these data indicate that paridiprubart provided a consistent and durable effect in patients across all severity groups evaluate; the company’s belief that these findings not only provide important validation of its therapeutic approach but also support paridiprubart’s potential use as a standard of care treatment for ARDS, and potentially chronic respiratory indications; and the company's timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements. Contact: Gary Koppenjan Edesa Biotech, Inc. [email protected]

TORONTO, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three and nine months ended June 30, 2025 and provided an update on its business. During the quarter, the company advanced manufacturing-related activities to support U.S. regulatory approval of a Phase 2 study of Edesa’s drug candidate EB06 (an anti-CXCL10 monoclonal antibody) in patients with moderate-to-severe nonsegmental vitiligo. Edesa anticipates drug manufacturing data for EB06 to be submitted to the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application by the end of calendar 2025 based on the current availability of manufacturing slots at third party service providers. “Our manufacturing plans are moving forward, and we’re energized by the opportunity to bring an innovative immunotherapy like EB06 into an area of high unmet need,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “We believe that the favorable safety profile of EB06, and its ability to target the immune system mechanisms impacting both lesional and non-lesional skin, has the potential to make it a preferable option for vitiligo patients – especially for those with lesions on more than 10% of their body surface area or those patients concerned about the safety risks of other treatments.” Edesa's Chief Financial Officer Peter Weiler reported that financial results for the quarter and fiscal year-to-date were in line with management expectations and continued to reflect the refocusing of company resources to its vitiligo development program. He noted that increased expenditures for Edesa’s EB06 program were offset by decreased expenses for its EB05 drug candidate as the company benefits from the fully funded U.S. government “Just Breathe” study of EB05 and other host-directed therapeutics in a general ARDS patient population. During the quarter, the government announced that the first randomizations for the platform study were completed. “We are channeling our operational efforts into regulatory preparation and drug manufacturing of our EB06 candidate with the goal of being in a position to move rapidly into clinical testing,” Mr. Weiler said. Financial Results for the Three Months Ended June 30, 2025 Total operating expenses for each of the three months ended June 30, 2025 and June 30, 2024 were $1.9 million: Research and development expenses were $0.9 million for each of the three months ended June 30, 2025 and June 30, 2024, as an increase in EB06-related expenses for Edesa’s planned Phase 2 vitiligo study was offset by a decrease in external research expenses related to the company’s investigational respiratory drug, EB05 (paridiprubart). General and administrative expenses were $1.0 million for each of the three months ended June 30, 2025 and June 30, 2024, as a decrease in salaries and related costs was offset by an increase in noncash share-based compensation and professional service fees. Total other income decreased by $110,000 to $154,000 for the three months ended June 30, 2025 compared to $264,000 for the same period last year. This decrease was primarily due to a decrease in reimbursement funding from the Canadian government's Strategic Innovation Fund as well as a decrease in interest income. For the quarter ended June 30, 2025, Edesa reported a net loss of $1.7 million, or $0.25 per common share, compared to a net loss of $1.7 million, or $0.52 per common share, for the quarter ended June 30, 2024. Financial Results for the Nine Months Ended June 30, 2025 Total operating expenses decreased by $0.6 million to $5.4 million for the nine months ended June 30, 2025 compared to $6.0 million for the nine months ended June 30, 2024: Research and development expenses decreased by $0.4 million to $2.4 million for the nine months ended June 30, 2025 compared to $2.8 million for the same period last year primarily due to a decrease in external research expenses related to EB05 (paridiprubart), which was partially offset by an increase in EB06-related expenses associated with preparations for the planned Phase 2 vitiligo study. General and administrative expenses decreased by $0.2 million to $3.0 million for the nine months ended June 30, 2025 compared to $3.2 million for the same period last year primarily due to a decrease in professional service fees and noncash share-based compensation. Total other income decreased by $0.3 million to $0.5 million for the nine months ended June 30, 2025 compared to $0.8 million for the same period last year, primarily due to a decrease in reimbursement funding from the Canadian government's Strategic Innovation Fund as well as a decrease in interest income. For the nine months ended June 30, 2025, Edesa reported a net loss of $5.0 million, or $0.95 per common share, compared to a net loss of $5.2 million, or $1.64 per common share, for the nine months ended June 30, 2024. Working Capital At June 30, 2025, Edesa had cash and cash equivalents of $12.4 million and working capital of $12.1 million. Calendar Edesa management is scheduled to participate in the Canaccord Genuity 45th Annual Growth Conference being held August 12-13, 2025 in Boston, Mass, and the H.C. Wainwright 27th Annual Global Investment Conference being held September 8-10, 2025 in New York, NY. Attendees interested in meeting with management can request meetings through the conference organizers or by contacting Edesa directly at [email protected]. About Edesa Biotech, Inc. Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is EB05 (paridiprubart), which is being evaluated in a U.S. government-funded platform study as a treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The EB05 program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset. Edesa is also pursuing additional uses for paridiprubart in chronic diseases, such as pulmonary fibrosis. Sign up for news alerts. Connect with us on X and LinkedIn. Edesa Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company’s belief that EB06 is an innovative immunotherapy and could provide benefits to an area of high unmet need; the company’s belief that EB06 has a favorable safety profile; the company’s belief that EB06 targets the immune mechanisms impacting both lesional and non-lesional skin, and this feature could make it a preferable option for vitiligo patients – especially for those with lesions on more than 10% of their body surface area or those concerned about the risks of other treatments; the company’s plans to channel its operational efforts into regulatory preparation and drug manufacturing of EB06 candidate with the goal of being in a position to move rapidly into clinical testing; the company’s plans to submit EB06 drug manufacturing data to the FDA IND application by the end of calendar 2025; and the company's timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements. Contact: Gary Koppenjan Edesa Biotech, Inc. [email protected]

TORONTO, May 14, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three and six months ended March 31, 2025 and provided an update on its business. During the quarter, the company completed a $15 million equity financing from healthcare-focused institutional investors, existing Edesa shareholders and insiders to support the development of the company’s vitiligo drug candidate EB06, anti-CXCL10 monoclonal antibody. The company has subsequently initiated outreach to potential investigators and manufacturing-related activities to support U.S. regulatory approval for a Phase 2 study in moderate-to-severe nonsegmental vitiligo patients. “The initial steps in the manufacturing of our biological drug are ongoing and we are excited about the potential of a novel immunotherapy like EB06. Vitiligo significantly impacts the lives of millions worldwide, yet there are no approved drugs that address the systemic nature of the disease. We believe we can ultimately change the treatment paradigm in much the same manner that immunotherapies have transformed other systemic autoimmune diseases like psoriasis,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. Edesa's Chief Financial Officer Peter Weiler reported that financial results for the quarter reflected a pivot in operational activity to the company’s vitiligo development program, from its respiratory program. Increased expenditures for the EB06 program were offset by decreased expenses for the EB05 drug candidate as the company benefits from a fully funded government study investigating Edesa’s respiratory drug as a treatment for Acute Respiratory Distress Syndrome (ARDS). “We are deploying additional resources to manufacturing and preparatory regulatory activities to speed the launch of our upcoming vitiligo study, and we anticipate that related research expenditures will generally track activity in this program,” Mr. Weiler said. Based on the current availability of manufacturing slots at third party service providers, Edesa reported that the company anticipates drug manufacturing data to be submitted to the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application in the second half of calendar 2025. Edesa anticipates topline results could be available within as few as 12 to 18 months following regulatory clearance by the FDA. The planned Phase 2 study is already approved in Canada. Financial Results for the Three Months Ended March 31, 2025 Total operating expenses decreased by $0.6 million to $1.6 million for the three months ended March 31, 2025 compared to $2.2 million for the three months ended March 31, 2024: Research and development expenses decreased by $0.7 million to $0.5 million for the three months ended March 31, 2025 compared to $1.2 million for the same period last year primarily due to decreased external research expenses related to manufacturing the company’s investigational drug, paridiprubart, which were partially offset by an increase in EB06-related expenses for the planned Phase 2 vitiligo study. General and administrative expenses increased by $0.2 million to $1.2 million for the three months ended March 31, 2025 compared to $1.0 million for the same period last year primarily due to an increase in salaries and related costs, which were partially offset by a decrease in noncash share-based compensation and professional service fees. Total other income decreased by $311,000 to $49,000 for the three months ended March 31, 2025 compared to $360,000 for the same period last year. This decrease was primarily due to a decrease in reimbursement funding from the Canadian government's Strategic Innovation Fund as well as a decrease in interest income. For the quarter ended March 31, 2025, Edesa reported a net loss of $1.6 million, or $0.30 per common share, compared to a net loss of $1.9 million, or $0.58 per common share, for the quarter ended March 31, 2024. Financial Results for the Six Months Ended March 31, 2025 Total operating expenses decreased by $0.6 million to $3.5 million for the six months ended March 31, 2025 compared to $4.1 million for the six months ended March 31, 2024: Research and development expenses decreased by $0.4 million to $1.5 million for the six months ended March 31, 2025 compared to $1.9 million for the same period last year primarily due to decreased external research expenses related to manufacturing the company’s investigational drug, paridiprubart, which were partially offset by an increase in EB06-related expenses for the planned Phase 2 vitiligo study. General and administrative expenses decreased by $0.2 million to $2.0 million for the six months ended March 31, 2025 compared to $2.2 million for the same period last year primarily due to a decrease in noncash share-based compensation and professional service fees, which were partially offset by an increase in salaries and related costs. Total other income decreased by $208,000 to $331,000 for the six months ended March 31, 2025 compared to $539,000 for the same period last year, primarily due to a decrease in interest income as well as a decrease in reimbursement funding from the Canadian government's Strategic Innovation Fund. For the six months ended March 31, 2025, Edesa reported a net loss of $3.2 million, or $0.74 per common share, compared to a net loss of $3.5 million, or $1.12 per common share, for the six months ended March 31, 2024. Working Capital At March 31, 2025, Edesa had cash and cash equivalents of $13.9 million and working capital of $13.5 million. Calendar Edesa plans to participate in the BIO International Convention being held June 16-19, 2025 in Boston, Mass. Attendees interested in meeting with company representatives can request meetings through the conference organizers or by contacting Edesa directly at [email protected]. About Edesa Biotech, Inc. Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is EB05 (paridiprubart), which is being evaluated in a U.S. government-funded platform study as a treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The EB05 program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset. In addition to EB05, Edesa is preparing an investigational new drug application (IND) in the United States for EB07 (paridiprubart) to conduct a future Phase 2 study in patients with pulmonary fibrosis. Sign up for news alerts. Connect with us on X and LinkedIn. Edesa Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company’s plans to seek and receive U.S. regulatory approval for a Phase 2 study of EB06 in moderate-to-severe nonsegmental vitiligo patients; the company’s belief in the transformational potential of a novel immunotherapy like EB06; the company’s belief that it can ultimately change the treatment paradigm for vitiligo in much the same manner that immunotherapies have transformed other systemic autoimmune diseases like psoriasis; the company’s ongoing plans to deploy additional resources to manufacturing, regulatory other preparations to speed the launch of its upcoming vitiligo study; the company’s anticipation that related research expenditures will generally track activity in this program; the company’s plans to submit drug manufacturing data to the FDA IND application in the second half of calendar 2025; Edesa’s anticipation that topline results could be available within as few as 12 to 18 months following regulatory clearance by the FDA; and; and the company's timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements. Contact:Gary KoppenjanEdesa Biotech, [email protected]